Compounder apparatus

ABSTRACT

A containment assembly for enclosing a medication container may comprise a first housing portion or interface portion having a proximal end and a distal end. The interface portion may include a housing wall which defines a channel spanning from the proximal end to the distal end. The channel may be open at the proximal and distal end. The containment assembly may further comprise at least one pierceable septum disposed at least at one of: on the proximal end of the channel and within the channel forming a barrier between the proximal end of the channel and distal end of the channel of the interface portion. The containment assembly may further comprise a variable-volume housing portion having a variable volume chamber. The variable-volume portion chamber of the variable-volume housing portion may be in fluid communication with the distal end of the channel.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. Ser. No.14/656,945, entitled “Compounder Apparatus”, filed on Mar. 13, 2015,which claims the benefit of U.S. Provisional Application Ser. No.61/953,036 filed Mar. 14, 2014 and entitled Compounder Apparatus, eachof which is hereby incorporated herein by reference in its entirety.

BACKGROUND

Field of Disclosure

The present disclosure relates to the creation of multi-ingredientmixtures. More specifically, the present disclosure relates to thecompounding of material, such as medications.

Description of Related Art

In many fields and for many applications, it is important to create amixture from a combination of multiple ingredients. To achieve a desiredend result, it is important that these ingredients are mixed with adegree of precision to ensure that each ingredient is present in aproper concentration when finished. Manual mixing of ingredients may beperformed; however, this may be inefficient, imprecise, error prone, andtime consuming among other draw backs. Additionally, some ingredientsmay be unsafe, or otherwise hazardous to mix by hand. It may, therefore,be desirable that an automated mixing apparatus be used.

SUMMARY

A compounder apparatus may include a manifold. A number of reservoirsmay be docked to the manifold. The compounder apparatus may include ameans of extracting fluid from the reservoirs. The compounder apparatusmay include a means of mixing the extracted fluid with a diluent. Thecompounder apparatus may include a mixing chamber for compoundingpharmaceuticals. The compounder apparatus may fill a destinationreservoir in communication with the compounder with the compoundedpharmaceutical.

In accordance with an embodiment of the present disclosure, acontainment assembly for enclosing a medication vial may comprise afirst housing portion or interface portion having a proximal end and adistal end. The interface portion may include a housing wall whichdefines a channel spanning from the proximal end to the distal end. Thechannel may be open at the proximal and distal end. The containmentassembly may further comprise at least one pierceable septum disposed atleast at one of: on the proximal end of the channel and within thechannel forming a barrier between the proximal end of the channel anddistal end of the channel of the interface portion. The containmentassembly may further comprise a variable-volume housing portion having avariable volume chamber. The variable-volume portion chamber of thevariable-volume housing portion may be in fluid communication with thedistal end of the channel.

In some embodiments the distal end of the interface portion may includea mating feature which mates with a cooperating mating feature of thevariable-volume housing portion. In some embodiments the containmentassembly may further comprise a gasket member configured to compressbetween the interface portion and the variable-volume housing portionwhen the interface portion is mated to the variable-volume housingportion. In some embodiments the containment assembly may furthercomprise an adapter member having a mating feature configured to matewith a cooperating mating feature on one of the interface portion andthe variable-volume housing portion. In some embodiments, the adaptermay be a collar which is adapted to fit around a portion of themedication vial. In some embodiments, the adapter may be a collar whichis adapted to fit around the neck of a medication vial. In someembodiments, the adapter may include at least one pass-through allowingfor fluid communication between the distal end of the channel and thevariable-volume portion chamber. In some embodiments, the containmentassembly may further comprise at least two pierceable septa disposedwithin the channel. A first septum of the at least two septa may bedisposed proximal the proximal end. A second septum of the at least twosepta may be disposed distal the proximal end relative to the firstseptum. In some embodiments, the variable-volume portion chamber may beformed from an elastomeric material. In some embodiments, thevariable-volume portion chamber may include at least one expandablefeature. In some embodiments, the at least one expandable feature may bea collapsible pleat. In some embodiments, the variable-volume housingportion may include a window.

In accordance with another embodiment of the present disclosure, acontainment assembly for enclosing a medication vial may comprise aninterface portion having a proximal end and a distal end. The interfaceportion may include a housing wall which defines a channel spanning fromthe proximal end to the distal end. The channel may be open at theproximal and distal end. The containment assembly may further comprise aplurality of elastomeric septa disposed within the channel forming abarrier between the proximal end of the channel and distal end of thechannel. The containment assembly may further comprise a variable-volumehousing portion. At least a portion of the variable-volume housingportion may be of variable volume and formed of an elastomeric material.

In some embodiments, the variable-volume portion chamber of thevariable-volume housing portion may be in fluid communication with thedistal end of the channel. In some embodiments, the second housingportion may include a pressure port configured for connection to apressure source. The pressure port may be a vacuum port and the pressuresource may be a vacuum source. In some embodiments, the variable volumemay be a flaccid enclosure. In some embodiments, the containmentassembly may further comprise a collar member which couples with one ofthe interface portion or variable-volume housing portion. The collarmember may be sized to fit around the neck of the medication vial. Insome embodiments, the collar member may include a passage which allowsfor fluid communication between the distal end of the channel and thevariable volume. In some embodiments, the collar member may comprise afirst part and a second part. The first and second part may havecooperating coupling features which engage to couple the first part andsecond part together.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other aspects will become more apparent from the followingdetailed description of the various embodiments of the presentdisclosure with reference to the drawings wherein:

FIG. 1 depicts a first example representative block diagram of acompounder;

FIG. 2 depicts a second example representative block diagram of acompounder;

FIG. 3 depicts a third example representative block diagram of acompounder;

FIG. 4 depicts a representation diagram of a compounder which isconfigured to reconstitute a drug which is in a powdered form;

FIG. 5 depicts a representational diagram of a compounder in whichvarious flow paths of a manifold are depicted;

FIG. 6 depicts a representational embodiment of a compounder in which alabeler and destination reservoir connection port are also shown andincluded;

FIG. 7 depicts a representational embodiment of a drug reservoircontainment assembly;

FIG. 8 depicts a representational embodiment of a drug reservoircontainment assembly;

FIG. 9 depicts an embodiment of a vial containment assembly;

FIG. 10 depicts a cross sectional view taken at a medial andlongitudinal plane of the vial containment assembly of FIG. 9;

FIG. 11 depicts an example embodiment of a drug reservoir containmentassembly;

FIG. 12 depicts an example embodiment of a drug reservoir containmentassembly;

FIGS. 13-15 depict various view of an example adapter for a drugreservoir containment assembly;

FIG. 16 depicts an example adapter for a drug reservoir containmentassembly;

FIG. 17 depicts a flowchart detailing a number of example steps whichmay be used in creating a desired pharmaceutical compound with acompounder;

FIG. 18 depicts a flowchart detailing a number of example steps whichmay be used by a compounder when placing a reservoir on a manifold;

FIG. 19 depicts a flowchart detailing a number of example steps whichmay be used by a compounder to manage a medication order queue when anew order is received;

FIG. 20 depicts a flowchart detailing a number of example steps whichmay be used by a compounder which is included in an integrated system toschedule compounding of drugs; and

FIG. 21 depicts a flowchart detailing a number of example steps whichmay be used in creating, with a compounder, a desired pharmaceuticalcompound having a manual additive.

DETAILED DESCRIPTION

FIG. 1 depicts an example representative block diagram of a compounderapparatus 10 (sometimes referred to herein simply as compounder 10 orapparatus 10) in accordance with an embodiment of the presentdisclosure. In specific embodiments, the compounder 10 may be adaptedfor use to precisely mix a number of products and solutions. Variousexamples may include, but are not limited to: soda, coffee, adultbeverages, chemicals, paint, parenteral nutrition formulations,pharmaceuticals, fillers, solvents, gases, etc. The example compounder10 depicted in FIG. 1 is shown as a pharmaceutical compounder. Such acompounder 10 may be used to prepare medications for any number ofapplications. In some embodiments, the compounder 10 may be used toprepare one or more of the following: chemotherapy drugs, epidurals,dialysis solution, cardioplegia drugs, etc. for later administration toa patient. Alternatively, in some embodiments, the compounder 10 may bepart of a bedside system which delivers fluid directly to a patient orto an apparatus that will deliver the fluid to the patient.

The compounder 10 may include a housing 12. The housing 12 may enclosevarious reservoirs, fluid pathways, valves, manifolds, chambers, controlcircuitry, sensors, etc. that are included as parts of the compounder10. The housing 12 may be any suitable enclosure constructed of anysuitable material or combination of suitable materials. In variousembodiments, the interior volume of the housing 12 may be a controlledenvironment, or may be divided into a number of controlled environments.In such embodiments, the controlled portion(s) of the housing 12 may besealed, insulated, etc. to facilitate control of that portion of thehousing 12.

In some embodiments, the interior volume or a portion of the interiorvolume of the housing 12 may be controlled to be relatively free ofparticulates and/or contaminates or meet a desired cleanroom standard.In such embodiments, the compounder 10 may include various filters (notshown) and circulation fans (not shown). Additionally, the interiorvolume of the housing 12 may be positively pressurized to help ensureair from an uncontrolled environment may not ingress into the housing 12in the event that there is a leak. The interior volume, or a portion ofthe interior volume of the housing 12 may be temperature controlled. Insuch embodiments, the compounder 10 may include thermal controlcomponents (not shown) such as a heater and/or refrigeration system,temperature sensors, etc. In some embodiments, the interior volume ofthe housing 12 may be controlled based on humidity, light levels orwavelengths, etc. and include such components as necessary to accomplishsuch control.

The compounder 10 may include a user interface 13. The user interface 13may be a graphic user interface such as a touch screen or any othersuitable user interface. The user interface 13 may be used by a user tocontrol operation of or program the compounder 10, check status of thecompounder 10, convey status messages from the compounder 10, providetroubleshooting or help screens to a user, etc.

In the example embodiment, the user interface 13 is shown as a part ofthe compounder 10, however, this need not be so in all embodiments. Insome embodiments, the user interface 13 may be external to thecompounder 10. For example, the user interface 13 may be accessedthrough a tablet, PC, smart phone, or any other suitable platform.

As shown, the compounder 10 includes a manifold 14. A number ofreservoirs 16 are docked on the manifold 14. In the example embodiment,five reservoirs may be docked on the manifold 14. In other embodiments,the manifold 14 may be adapted such that any suitable number ofreservoirs 16 may be docked on a manifold 14. This may be desirable inorder to make a compounder 10 more versatile and able to concoct alarger number of compounded medications or other mixtures. Someembodiments may include more than one manifold 14. For example, theremay be a number of manifolds 14 arranged in parallel. This may also helpto increase the range of compounded medications or mixtures which thecompounder 10 may create. Additionally, having multiple manifolds 14 mayhelp to increase the overall throughput of a compounder 10. In somespecific embodiments, the manifold(s) 14 may be configured to dock atleast 63 reservoirs 16.

A manifold 14 for the compounder 10 may be constructed in any suitablemanner. In some embodiments, the manifold 14 may be machined, injectionmolded, or generated with an additive manufacturing process such asselective laser sintering, etc. It may also be desirable that a manifold14 for the compounder 10 be of a material which will not be compromisedby repeated sterilization. For example, it may be desirable that amanifold 14 be made from high temperature, heat resistant plastic.

The reservoirs 16, in the example embodiment, may be medication vials.In other embodiments, the reservoirs 16 may not be medication vials. Inapplications where the compounder 10 is adapted for use in beveragemixing the reservoirs 16 may contain drink concentrates, liquors, drinkadditives, etc. In applications where the compounder 10 is adapted foruse in paint mixing, the reservoirs may be various colors of paint. Inother embodiments, the reservoirs 16 may contain other fluids,solutions, materials, etc.

Fluid may be selectively extracted from the reservoirs 16 and into themanifold 14. This may be done in any suitable fashion. In someembodiments, a positive pressure may be created in the reservoir 16 suchthat fluid is forced out of the reservoir 16. In some embodiments, avacuum or partial vacuum may be drawn downstream of the reservoir 16 tosuck fluid out of the reservoir 16. In some embodiments, a reservoir 16may be elastomeric and may exert a force on the fluid contained withinthe reservoir 16 that squeezes the contained fluid out of the reservoir16. In some embodiments, a reservoir 16 may be flaccid or flexible andbe surrounded by an inflatable bladder or pressurizable chamber. As thebladder is inflated or the pressurizable chamber is pressurized, theflaccid reservoir 16 may be forced to collapse and fluid may be forcedout of the reservoir 16.

The manifold 14 may include various valves to facilitate extraction offluid from the reservoirs 16 in a controlled manner. For example, avalve may be positioned downstream of a reservoir dock on a manifold 14.As pressure is exerted on the fluid in a reservoir 16 on that dock orport, the valve may be opened and closed to allow a desired amount offluid to escape from the reservoir 16. Each time the valve is opened andclosed the volume of fluid which escapes from the reservoir 16 may bemeasured. The valve may be cycled open and closed until the properamount of fluid has left the reservoir 16

Fluid from the reservoir 16 may be routed through the various fluidpassageways of the manifold 14 and into a mixing chamber 18.Additionally, the mixing chamber 18 may be selectively put intocommunication with a diluent source 20. In the mixing chamber 18,diluent from the diluent source 20 may be added to the fluid from thereservoirs 16 to dilute the reservoir 16 fluids to a lowerconcentration. In some embodiments, multiple diluent sources 20 may beincluded. This may be desirable since different medications may need tobe diluted with different diluents. In some embodiments, the mixingchamber 18 may be actively agitated or otherwise controlled in a mannerthat would facilitate mixing of fluid in the mixing chamber 18.

A valve 22 may be actuated to allow fluid to flow from the mixingchamber 18 to a fluid line 23 and into a destination reservoir 24. Thedestination reservoir 24 may be any type of suitable reservoir for acompounded medication or mixture. In the example embodiment, thedestination reservoir 24 is shown as an IV bag. Other types ofmedication reservoirs may also be used as the destination reservoir 24.For example, a medication vial, syringe, bladder, cassette, or any otherdrug containing volume or vessel may be used as a destination reservoir24. In some embodiments, a patient may be the reservoir 24.

In embodiments where the compounder 10 is not a pharmaceuticalcompounder, the destination reservoir 24 may differ. For example, if thecompounder 10 is for use in the mixing of beverages, the destinationreservoir 24 may be a cup, glass, bottle, can, mug, thermos, or thelike. In embodiments where the compounder 10 is for use in the mixing ofpaints, the destination reservoir 24 may be a paint can or the like.

FIG. 2 depicts another example embodiment of a compounder 10. Thecompounder 10 shown in FIG. 2 includes a gantry 30. The gantry 30 may beused move reservoirs 16 onto and off of a manifold 14. In otherembodiments, any other means of moving reservoirs 16 onto and off of themanifold 14 may be used. For example, a mechanized armature or the likemay be used.

The gantry 30 may be controlled by a controller 31 The controller 31 maycommand movement of a crane 32 of the gantry 30 using, for example, anx,y coordinate system. As shown in FIG. 2, a reservoir 16 is held by thecrane of the gantry 30. The crane 32 of the gantry 30 has beenmaneuvered over an open port of the manifold 14 in FIG. 2. This may beaccomplished by the controller 31 commanding the crane 32 of the gantry30 to move to the specific coordinate of the open port on the manifold14. The controller 31 may then lower crane 32 to place the reservoir 16on the manifold 14. The manifold 14 may include a retaining feature orthe like to ensure that the reservoir 16 is securely held on themanifold 14. Additionally, in some embodiments, the interface betweenthe reservoir 16 and the manifold 14 may be made to be fluid tight insome embodiments.

In some embodiments, the controller 31 may cause a unique identifier 34on a reservoir 16 to be read before moving the reservoir 16 to an openport on a manifold 14. The unique identifier 34 may be any variety ofunique identifier 34 and may identify the contents of the reservoir 16.The unique identifier 34 may be a barcode, RFID, magnetic strip, othersmart identification, etc. There may, for example, be a uniqueidentifier 34 for each drug (and each form and concentration of eachdrug if it comes in multiple forms/concentrations) which may be used inthe compounder 10.

Based on the unique identifier 34, the controller 31 may identify anumber of compatible ports on the manifold (s) 14. The controller 31 maythen command the gantry 30 to move to a selected port of the compatibleports. For a compounder 10 used in the compounding of pharmaceuticals,compatible ports may, for example, be ports on manifolds 14 which do notinclude a contraindicated drug or ports on manifolds 14 made fromcompatible materials. In some embodiments, instead of identifying anumber of compatible ports for a unique identifier 34, each uniqueidentifier 34 may have an assigned manifold 14 port. Ports may be chosenfor each unique identifier 34 in a manner which maximizes throughput,efficiency, and/or safety of the compounder 10.

In some embodiments, a user may instead or additionally manuallyidentify the contents of the reservoir 16 on a user interface of thecompounder 10. In embodiments where this is done in addition to thereading of a unique identifier 34 on the reservoir 16, the compounder 10may generate an error if the contents of the reservoir 16 manually inputby a user do not match the contents of the reservoir 16 as indicated bythe unique identifier 34. Additionally, a user may identify whichmanifold 14 port they would like the reservoir 16 to be docked to insome embodiments. In such embodiments, if the port selected isincompatible (e.g. is on a manifold 14 with a contraindicatedmedication) with the contents of the reservoir 16 the compounder 10 maygenerate an error and not allow docking.

To remove a spent reservoir 16 from the manifold 14, the controller 31may move the crane 32 of the gantry 30 to the location of the port ofthe manifold 14 where the spent reservoir 16 is docked. The crane 32 maythen be lowered to the reservoir 16, pick up the reservoir 16 and removethe reservoir 16 from the manifold 14.

As mentioned above, in some embodiments, the manifold 14 may include aretaining feature which ensures that the reservoir 16 is securelyretained on the manifold 14. In such embodiments, the crane 32 mayinclude an unlocking feature which must engage with a portion of themanifold 14 for the reservoir 16 to be released from the retainingfeature. When the crane 32 is lowered to the desired port on themanifold 14 correctly, the unlocking feature may operatively engage aportion of the manifold 14 such that the retaining feature may releasethe reservoir 16. Likewise, in some embodiments, a reservoir 16 may notbe placed on the manifold 14 without the unlocking feature of the crane32 engaging the appropriate portion of the manifold 14. In suchembodiments, the retaining feature may also act as a receiving featurewhich precludes docking of a reservoir 16 on the manifold 14 unless theunlocking feature is properly engaged with the manifold 14.

In some embodiments, when a spent reservoir 16 is removed from amanifold 14 port, a controller 31 may command the gantry 30 to move tothe coordinates of a bin or container (not shown) within the compounder10. Such a bin or container may be used to store spent reservoirs 16.The bin or container may be removable once full. In some embodiments,the bin or container may seal once removed from the compounder 10. Onceremoved the bin or container may be replaced with a new bin orcontainer.

In some embodiments, after removing a spent reservoir 16 the controller31 may command the gantry 30 to retrieve a cover member for the manifold14 port. The crane 32 may then place the cover member over the manifold14 port. Alternatively, the controller 31 may command the gantry 30 toretrieve a cleaning or sterilizing cartridge which may then be placedover the port and used for cleaning or sterilization of the port.

Instead of moving randomly about a manifold 14 or number of manifolds14, it may be desirable that the gantry 30 be controlled to work onmanifold 14 ports which are in close spatial proximity to one anotherwhen possible. This may help to increase efficiency and throughput ofthe compounder 10.

FIG. 3 depicts another example embodiment of a compounder 10. As shown,the compounder 10 includes a number of manifolds 14. As previouslymentioned, other embodiments may include a greater or lesser number ofmanifolds 14. As shown, all of the manifolds 14 are arranged inparallel. This arrangement may help to increase throughput of thecompounder 10 since more than one manifold 14 may deliver fluid to amixing chamber 18 simultaneously. This may further be advantageous for avariety of other reasons. For instance, such an arrangement would allowreservoirs 16 containing contraindicated drugs to be placed on separatemanifolds 14. It would allow for some reservoirs 16 to be contained in adifferent controlled environment (e.g. different temperature zones)within the compounder 10 housing 12. Additionally, it may allow formanifolds 14 to be made of a variety of materials. Thus, reservoirs 16may be placed on manifolds 14 made from compatible materials.

As shown, all of the manifolds 14 are plumbed into the same mixingchamber 18. In some embodiments, each manifold 14 may be associated withits own mixing chamber 18.

In the embodiment depicted in FIG. 3, each of the reservoirs 16 isenclosed within a reservoir receptacle or cartridge 50. It may bedesirable to enclose a reservoir 16 within a cartridge 50 if thereservoir 16 contains hazardous contents. In applications where thecompounder 10 is for use in the compounding of pharmaceuticals, it maybe desirable to have various drugs enclosed in a cartridge 50. Forexample, some drugs, such as those used in chemotherapy applications,may give off dangerous vapors or may be harmful if they contact ahandler. The cartridge 50 may be used to seal the drug containingreservoir 16 such that vapors and/or fluids may not exit the cartridge50 and pose a hazard to users of the compounder 10. In some embodiments,the cartridge 50 itself may seal the reservoir 16 from the surroundingenvironment. In some embodiments, the cartridge 50 may contain a closurewhich may facilitate sealing. The cartridge 50 may then interface withthe manifold 14 such that the cartridge 50 may be docked on the manifold14

In other embodiments, the cartridge 50 may cooperate with one or moreadditional component to create a seal. Some embodiments may use acartridge 50 similar to the vial receptacle, shown and described in U.S.Pat. No. 8,158,102, issued Apr. 17, 2012 and entitled SYSTEM, DEVICE,AND METHOD FOR MIXING A SUBSTANCE WITH A LIQUID, which is incorporatedherein by reference in its entirety. In such embodiments, the cartridge50 may be spiked with a spike receptacle in a vial spike assembly alsoas shown and described in just referenced U.S. Pat. No. 8,158,102.

For some applications, the reservoirs 16 need not be enclosed and sealedusing a cartridge 50. For example, it may not be necessary for drugsused by a compounder 10 which pose less of a handling hazard to besealed. In such instances, bare reservoirs 16 may be docked on themanifold 14. These reservoirs 16 may come in a number of differentstyles, types, sizes or dimensions. In some embodiments, adapter membersmay also be included for each reservoir 16 variety. The adapter membersmay fit around and/or over a portion of the reservoirs 16. The adaptermembers may also have a standardized connecting feature or fitting. Theconnecting feature may allow the ports of the manifolds 14 to bestandardized to a single size, geometry, etc. Thus, a reservoir 16 withthe proper adapter attached may be placed on any suitable manifold 14port regardless of the dimensions, type, style, etc. of the reservoir16. Alternatively, manifolds 14 may include dedicated ports for eachvariety of reservoir 16 or the compounder 10 may include designatedmanifolds 14 for each variety of reservoir 16. In other embodiments, themanifolds 14 may interface with specifically designed reservoirs 16.This may ensure that only reservoirs 16 made for use in the compounder10 are able to be used with the compounder 10.

In addition to reservoirs 16 coming in a number of different styles,types, sizes or dimensions, the stoppers (not shown) used in thesereservoirs 16 may also vary. The stoppers may affect the distance that aspike for the reservoir 16 may penetrate into the interior volume ofthat reservoir 16. Since, for example, it would be desirable that anoutlet spike for a reservoir 16 be located toward the bottom of thereservoir volume 16, in some embodiments, adapter members may similarlybe included for each stopper variety. Such adapters may functionsimilarly to those described above, however, may also ensure that thereservoir 16 is located at a distance from the manifold 14 which ensuresthe spike is at a suitable location within the reservoir volume when thereservoir 16 is docked to a manifold 14.

It may be desirable that the reservoir-manifold interface or manifold 14port be made aspetic or sterilizable for certain compounder 10applications. In the compounding of pharmaceuticals, this may beparticularly desirable. In some embodiments, the compounder 10 mayinclude one or more cleaning cartridge 52. In the embodiment depicted inFIG. 3, a cleaning cartridge 52 is docked to the farthest right port ofthe foremost manifold 14. In some embodiments, a steam line (not shown)may be plumbed into communication with a cleaning cartridge 52. Thecleaning cartridge 52 may be placed over the desired manifold 14 portand steam may be allowed to fill the cleaning cartridge 52. This steammay sterilize the manifold 14 port. During cleaning with the cleaningcartridge 52, any valves for fluid pathways leading to or from aselected manifold 14 port may be closed.

Alternatively, the compounder 10 may be configured to move an entiremanifold 14 to a sterilizing chamber in the housing 12 of the compounder10. This may, for example, be accomplished with a gantry such as thegantry 30 shown in FIG. 2. In some embodiments, the sterilizing chambermay be a steam chamber. Such a sterilizing scheme may, however, slowthroughput of the compounder 10.

In some embodiments, materials used by a compounder 10 may not come in aliquid form. For example, some drugs may come in a powdered orlyophilized form. Such drugs may need to be reconstituted beforecompounding or administration to a patient. In some embodiments, suchmaterials may be reconstituted by a user before being provided to acompounder 10. In other embodiments, a compounder 10 may be configuredto reconstitute the material. FIG. 4 depicts a representation diagram ofa compounder 10 which is configured to reconstitute a drug which is in apowdered form.

As shown, the compounder 10 includes a manifold 14. A number ofreservoirs 16 are docked on the manifold 14. The manifold 14 in FIG. 4is also in communication with a reconstituting component 70. Someembodiments may include additional reconstitution components 70. Asshown, a reservoir 16 is docked on the reconstituting component 70. Thereservoir 16 on the reconstituting component 70 may include a powdereddrug.

As shown, the reconstituting component 70 may also be placed intocommunication with a diluent source 20. As shown, diluent may be pumpedfrom the diluent source 20 using a diluent pump 72. In otherembodiments, fluid may flow from the diluent source 20 by means of agravity feed. In other embodiments, fluid may be compelled to leave thediluent source 20 by any number of other suitable means. Such suitablemeans may include, but are not limited to, creating a positive pressurein the diluent source 20 container, creating a vacuum downstream of thediluent source 20, squeezing or collapsing the diluent source 20container, etc.

In the example embodiment, when a diluent valve 74 is appropriatelyactuated, the diluent may flow to the reconstitution component 70. Asshown, check valves 78 are included to ensure that no diluted medicationmay enter the diluent lines. The reconstitution component 70 mayreconstitute the drug. In some embodiments, this may be accomplished bypumping diluent into the reservoir 16. The reservoir 16 or diluent inthe reservoir 16 may be actively agitated to encourage the powdered drugto go into solution quickly. In some embodiments, the diluent may bepumped back and forth between the reservoir 16 and a reconstitutionchamber 76 in the reconstitution component 70 in order to fullyreconstitute the drug.

In some embodiments, the reconstituted solution may be agitated for anempirically derived predetermined period of time for each drug. Theperiod of time may be a tested period of time sufficient for thepowdered drug within the reservoir 16 to go into solution plus anadditional margin. In some embodiments, the reconstitution component 70may include one or more sensor (not shown). For example, thereconstitution component 70 may include a conductivity probe which maybe used to detect whether or not the drug has fully gone into solution.In some embodiments, the reconstitution component 70 may include anoptical sensor which monitors for particulates which would indicate thatthe drug has yet to fully go into solution. In some embodiments, thereconstitution component 70 may include one or more sensor to monitorthe volume of diluent used to reconstitute the drug. The reconstitutioncomponent 70 may also include one or more sensor which may measure thevolume of the reconstituted drug. Such an arrangement would allow acontroller to compare the volume of diluent to the reconstituted drugvolume to determine the drug concentration.

In some embodiments the reconstituting component may include areconstituting cassette similar to as described in U.S. Pat. No.6,210,361, issued Apr. 3, 2001 and entitled SYSTEM FOR DELIVERINGINTRAVENOUS DRUGS, which is incorporated herein by reference in itsentirety. Such a cassette may also be used in place of the manifolds 14described herein.

Once the drug has been reconstituted, it may be allowed to flow to afluid path of a manifold 14 and on to a mixing chamber 18. In otherembodiments, the drug may flow from the reconstitution component 70 tothe mixing chamber 18. In other embodiments, other non-liquid materialsmay be reconstituted and mixed by a compounder 10. For example, inembodiments where the compounder 10 is not used in a pharmaceuticalapplication, the compounder 10 may reconstitute powdered drink mix.

FIG. 5 depicts a representational diagram of a compounder 10 in whichvarious flow paths of a manifold 14 are depicted. As shown, eachreservoir 16 docked on the manifold 14 has been spiked such that it maybe placed in communication with the various fluid pathways of themanifold 14. In the example embodiment, each reservoir 16 is spiked withan inlet 92 and an outlet 94. The inlet 92 and outlet 94 may be twoseparate needles or a double lumen needle in some embodiments. In otherembodiments only a single needle may be used. In still otherembodiments, more than two needles may be used.

As shown, the manifold 14 is in communication with a clean air reservoir90. The clean air reservoir 90 in the example embodiment is apressurized tank of clean, medical grade air. In other embodiments, theclean air reservoir 90 may differ. For example, in some embodiments, theclean air reservoir 90 may be part of a clean air system included in thecompounder 10. In such embodiments, the clean air reservoir 90 may be anaccumulator for a compressor pump (not shown). The pump may pump inambient air. This air may pass through appropriate filters, dryers, etc.to ensure it is suitable for use in the compounder 10.

Clean air from the clean air reservoir 90 may selectively be routed intodesired reservoirs 16 on the manifold 14. To facilitate this, themanifold 14 may include a number of valves 96. The valves 96 may openand close the fluid path between the clean air reservoir 90 and inlet 92for each reservoir 16. When the fluid pathway is open, clean air mayflow into the reservoir 16 from the pressurized clean air reservoir 90.This may create a positive pressure in the reservoir 16 and force fluidout of the reservoir 16 through the outlet 94. In some embodiments, thevolume of air which may flow into a reservoir 16 may be controlled so asto displace a desired amount of fluid from the reservoir 16. This may,for example, be accomplished by cycling the valves 96 associated witheach reservoir 16 to achieve a desired flow rate. It may be desirablethat the inlet 92 is configured to be positioned near the top of theinterior volume of the reservoir 16 when the reservoir 16 is spiked.This may help to minimize concern for creation of air bubbles whenforcing fluid out of the reservoir 16. It may also be desirable that theoutlet 94 be near the bottom of the reservoir 16. This may help toensure that all of the fluid within the reservoir 16 may be used by thecompounder 10. As mentioned above, not all embodiments may create apositive pressure in a reservoir 16 to draw fluid out of the reservoir16. The compounder 10 may be configured to use any other suitable meansof drawing fluid from a reservoir 16 such as those mentioned above.

The valves 96 may be any suitable variety of valve. In some embodiments,the valves 96 may be solenoid type valves. In other embodiments, thevalves 96 may be bi-stable valves such as those disclosed in U.S.Provisional Application Ser. No. 61/844,202, filed Jul. 9, 2013 andentitled VALVE APPARATUS AND SYSTEM; U.S. patent application Ser. No.14/327,206, filed Jul. 9, 2014 and entitled VALVE APPARATUS AND SYSTEMand U.S. Provisional Application Ser. No. 62/091,351, filed Dec. 12,2014 and entitled MODULAR VALVE APPARATUS AND SYSTEM, each of which isincorporated herein by reference in its entirety.

Once fluid travels from the reservoir 16 through the outlet 94, it maypass through a check valve 98. The fluid may then flow to a mixingchamber 18. As shown, each outlet includes a check valve 98. This mayensure that fluid from one reservoir 16 may not enter another reservoir98 through that reservoir's 16 outlet 94. Additionally, it may ensurethat during flushing of the manifold 14, fluid may not enter any of thereservoirs 16.

As shown in FIG. 5, the manifold 14 is configured such that clean airfrom the clean air reservoir 90 may be used to flush the manifold 14. Toflush the manifold 14, a flush valve 100 may be opened. Opening theflush valve 100 may place the fluid pathways for fluid leaving thereservoirs 16 into communication with clean air reservoir 90.Pressurized air may then flow through these fluid pathways flushing outremaining fluid. As shown in the example embodiment, a check valve 98 isalso included downstream from the flush valve 100 to preclude fluid fromthe reservoirs 16 from flowing back to the clean air reservoir 90 orother undesired fluid pathways of the manifold 14. The flush valve 100may be any suitable type of valve. In some specific embodiments, theflush valve 100 may be a bi-stable valve such as those disclosed in U.S.Provisional Application Ser. No. 61/844,202, filed Jul. 9, 2013 andentitled VALVE APPARATUS AND SYSTEM; U.S. patent application Ser. No.14/327,206, filed Jul. 9, 2014 and entitled VALVE APPARATUS AND SYSTEMand U.S. Provisional Application Ser. No. 62/091,351, filed Dec. 12,2014 and entitled MODULAR VALVE APPARATUS AND SYSTEM, each of which isincorporated herein by reference in its entirety.

In alternative embodiments, diluent from a diluent source 20 may bepumped through these fluid pathways to flush out any remaining fluid. Inother embodiments, the manifold 14 may be flushed with both clean airfrom the clean air reservoir 90 and diluent from the diluent source 20.

In some embodiments, the manifold 14 may instead or additionally be putinto communication with a steam source or other hot fluid source and beperiodically flushed with fluid from this source for cleaning purposes.In some embodiments, when a reservoir 16 is spent, steam or othersuitable hot fluid may be routed through the manifold 14 and into thereservoir 16. This may be done to clean the manifold 14 port withoutremoving the spent reservoir 16.

In some embodiments, any fluid from a manifold 14 flushing may bedirected to a dump location or flush discard reservoir. Additionally, insome embodiments, after a manifold 14 or manifold 14 port is cleaned,the manifold 14 may be flushed to remove dead pathogens or other matter.

In some embodiments, the manifold 14 may include additional components.For example, the manifold 14 may include an air bubble detector (notshown). The manifold 14 may also include an occlusion detector (notshown). The manifold 14 may also include sensors (not shown) at eachmanifold 14 port which sense whether a reservoir 16 has been docked onthat port. In some embodiments, such sensors may also sense whether areservoir 16 is improperly docked on a port.

As mentioned above, fluid from the reservoirs 16 may travel from themanifold 14 to a mixing chamber 18. A mixing chamber 18 may be used tomix fluid from one or multiple reservoirs 16 with diluent from a diluentsource 20. In various embodiments, the size of the mixing chamber 18 maydiffer. In some embodiments, the mixing chamber 18 may be sized suchthat it may be filled and dispensed a plurality of times to fill adestination reservoir 24. In some embodiments, the mixing chamber 18 maybe sized such that it need only be filled and dispensed a single time tofill a destination reservoir 24. In some embodiments, the mixing chamber18 may be a reusable component of the compounder 10. That is, the samemixing chamber 18 may be used repeatedly as multiple pharmaceuticalcompounds are compounded by the compounder 10. In other embodiments, themixing chamber 18 may be a limited (e.g. one time) use disposable whichmay be replaced after each pharmaceutical compound is compounded by thecompounder 10. In such embodiments this replacement may be doneautomatically.

The mixing chamber 18 may be monitored by one or more sensor 102. Theone or more sensor 102 may track the volume of fluid entering the mixingchamber 18. Thus the one or more sensor 102 may be used to ensure thatfluids entering the mixing chamber 18 are combined in properconcentrations. In some embodiments, the one or more sensor 102 may beselected from one or a combination of the following: an acoustic volumesensor, a capacitance sensor, an ultra-sonic sensor, a range finder etc.Additionally or alternatively, in some embodiments, a piezoelectric jetmay be used to control the flow of fluid into the mixing chamber 18.

In some embodiments, the mixing chamber 18 may be similar to a dripchamber. In such embodiments, the one or more sensor 102 may include acamera which monitors fluid in the mixing chamber 18. In suchembodiments, the camera may measure the volume of fluid entering themixing chamber 18 to determine when a proper amount of a fluid hasentered the mixing chamber 18. In some embodiments, the camera may alsobe used to determine flow rate of fluid into the mixing chamber 18. Insome embodiments, the camera may be used to determine when to halt fluidflow into the mixing chamber 18 or when to deliver fluid in the mixingchamber to a destination reservoir 24.

FIG. 6 depicts a representational embodiment of a compounder 10 in whicha labeler 120 and destination reservoir connection port 122 are shown.As shown, the reservoir connection port 122 may serve as the interfacebetween the compounder 10 and a destination reservoir 24. A destinationreservoir 24 may couple to a reservoir connection port 122 such that thecompounder 10 is placed in fluid communication with the destinationreservoir 24. The reservoir connection port 122 may be a part of thecompounder 10 and may be reused each time a destination reservoir 24 isattached. As shown, there are two destination reservoirs 24 attached tothe connection port 122 by means of a y-site connector 124. In someembodiments, the y-site connector 124 may be included as part of theconnection port 122. In other embodiments, suitable connectors may beincluded to allow additional destination reservoirs 24 to be connected.Alternatively, a manifold (not shown) may be included to route fluid toone of plurality of desired destination reservoirs 24.

Connecting multiple destination reservoirs 24 may be desirable if thecompounder 10 is commanded to produce a large volume of the samepharmaceutical compound because it may help to increase throughput. Thismay be so because the compounder 10 would not need to stop to allow auser to time to disconnect a destination reservoir 24, clean theconnector port 122, and connect another destination reservoir 24. In apreferred embodiment, the connection port 122 may be a standard fittingwhich may connected to any of a variety of destination reservoirs 24. Insome embodiments, or for some destination reservoirs 24 various adaptersmay be used when coupling the connection port 122 to a destinationreservoir 24.

Before a destination reservoir 24 may be connected to the compounder 10,it may be desirable that the connection port 122 be sterile. In someembodiments, the connection port 122 may come as a sterile disposablewhich is replaced as needed. In other embodiments, the connection port122 may be configured to be sterilizable. Any suitable means ofsterilizing the connection port 122 may be used. The connection port 122should be made of a material which will not degrade with repeatedsterilization. In some embodiments, the connection port 122 may besterilized by means of a steam bath or steam jet. In some embodiments,the connection port 122 may be cleaned with ultra-violet light. In someembodiments, radiation may be used to sterilize the connection port 122.In some embodiments, the connection port 122 may be made of metal andmay be inductively heated to a suitable temperature for sterilization.In other embodiments, the connection port 122 may be heated by othermeans for sterilization purposes. In some embodiments, any combinationof suitable means to sterilize the connection port 122, including thoughnot limited to those described above, may be used.

As shown, the compounder 10 may also include or interface with a scaleor load cell 126. The load cell 126 may be configured as a shelf, tray,holder, or the like for the destination reservoir 24 during filling ofthe destination reservoir 24. The load cell 126 may be used for checkingthe compounded solution with by gravimetric means. After the destinationreservoir 24 has been filled with the proper volume of compoundedsolution, the weight of the destination reservoir 24 as measured by theload cell 126 may be checked against an expected weight. If the weightof the destination reservoir 24 is within a predetermined range of theexpected weight, the compounder 10 may signal the destination reservoir24 is ready for use and may be removed. If the weight of the destinationreservoir 24 is outside of the predetermined range, the compounder 10may generate an error and indicate that that destination reservoir 24should not be used.

Once the compounder 10 has filled a destination reservoir 24 with thecompounded drug, the compounder 10 may generate a label for thedestination reservoir 24. This label may be generated by a labeler 120included as a part of the compounder 10. The labeler may label thedestination reservoir 24 with one or more of a unique identifier,compound name, medications used in the compound, an administrationprofile, a patient identifier, the destination reservoir 24 weight, ause by time or date, and so on. The labeler 120 may produce any suitablevariety or label, for example, adhesive backed information print out,barcode, RFID, magnetic strip, etc. In some embodiments, a customer maychose which type of labeler 120 they would like included on a compounder10. This may be desirable because it would allow a customer to pick alabeler 120 which would best interface with their institution. In someembodiments, the labeler 120 may also place the label on the destinationreservoir 24 in an automated fashion. In other embodiments, the labelingof a destination reservoir 24 may be done manually. As mentioned, insome embodiments, the label may include use by information. Inembodiments where the label must be read or scanned by another device,the device may notify the user that the destination reservoir 24contains medication with is past is use by time or date. In someembodiments, the device may disallow usage of the destination reservoir24.

In some embodiments, the compounder 10 may also generate a report foreach compounded pharmaceutical. In such embodiments, these reports maybe printed via a labeler 120 or may be saved electronically and laterdownloaded from the compounder 10.

FIG. 7 depicts a representational example embodiment of a drug reservoircontainment assembly 300 and a compounder dock 302. As shown, the drugreservoir containment assembly 300 is not in place on the compounderdock 302. As mentioned, the drug reservoir containment assembly 300 maybe used to ensure that any hazardous vapors or substances are containedand prevented from entering the ambient environment.

A drug reservoir containment assembly 300 may generally include one ormore enclosing structures or housing sections and an adapter whichallows the enclosing structures to receive a plurality of reservoirs(e.g. vials, bags, etc.). The enclosing structures and adapter may mateand or assemble together to form a sealed or air-tight interior volumewhere the drug reservoir may be held or retained. The containmentassembly 300 may include one or more windows which allow a user to viewthe contents of the containment assembly 300. The containment assembly300, in some embodiments, may be clear, translucent, or transparent toallow a user to view the contents of the containment assembly, or togenerally view the interior of the containment assembly 300.

The adapter may be a separate component or alternatively may be anintegral part of an enclosing structure. Suitable sealing members(gaskets, o-rings, etc.) may be included to ensure that the drugreservoir containment assembly 300 is sealed from the environment whenassembled. At least one enclosing structure may include one or moreseptum which may be pierced by a spike of a compounder. The one or moreseptum may be disposed in a channel which extends from a proximal end ofan enclosing structure to a distal end of the enclosing structure andmay form a barrier between the proximal and distal end of the channel.The septum may be made of a self healing material and allow for a sealto be maintained when a drug reservoir containment assembly 300 has beenspiked during use. Additionally, a portion of a drug reservoircontainment assembly 300 may act as a sealed receiving volume for anyhazardous substances or vapors which may escape a drug reservoir. Insuch embodiments, the receiving volume may be negatively pressurized andmay be rigid or expandable. In various embodiments, at least a portionof the enclosing structure or housing section having the receivingvolume may be of variable volume.

As shown in the specific example in FIG. 7, the drug reservoircontainment assembly 300 is a vial containing assembly. Similarcontainment assemblies may be used for other types of drug reservoirs.The example containment assembly 300 includes a vial receiving assembly304 which receives a vial 306. The vial 306 is enclosed and sealedwithin the vial receiving assembly 304.

As shown, the receiving assembly 304 includes two enclosing portions: adock interface portion 308 and a variable volume housing portion 312.The receiving assembly 304 also includes an adapter 310. The dockinterface portion 708 interfaces with a compounder dock 302 and mayinclude an interface structure 314. The interface structure may be arigid body which surrounds the stopper and crimp of a vial 706.Additionally, the interface structure 314 may include a feature whichlocks into or mounts into the compounder dock 702 in any of a variety ofways. In various embodiments, the interface structure 314 may threadinto, snap into, magnetically mate, bayonet mount into, or otherwise besecured into the compounder dock 302.

An interface portion 308 of a drug reservoir receiving assembly 300 mayinclude at least one septum. This septum may span an opening in theinterface portion 308 creating an elastomeric seal. In the exampleembodiment shown in FIG. 7, the interface portion 308 includes a firstseptum 316 and a second septum 318. Other embodiments may include agreater or lesser number of septa. These septa 316, 318 may be made anelastomer, rubber, a flexible polymer, resilient material, or anyelastomeric or self healing material which is capable of being piercedby a needle 322 and maintaining a seal and wiping the needle when theneedle 322 is withdrawn.

The example receiving assembly 304 also includes an adapter 310 asmentioned above. The adapter 310 may fit around a portion of a vial 306allowing the vial 306 to coupled into a standard interface portion 308.In the example embodiment, the adapter 310 is shown around the neck ofthe vial 306. In other embodiments, the adapter 310 may fit aroundanother portion of the vial 306 or may be included as part of theinterface portion 308. Different adapters 310 may be used depending onthe vial type 306. Alternatively, the adapter 310 may be standard andinclude a variable aperture or cinching mechanism which allows theadapter 310 to adapt itself to a range of different vial 306 types. Insome specific embodiments, the adapter 310 may be a collar which fitsaround the vial 306 neck. In some embodiment, the adapter 310 may beinclude two pieces which may be coupled together around a suitableportion of a vial (e.g. the neck). In such embodiments, the pieces maysnap, or friction fit together, be bonded (adhesive, solvent, etc.)together, magnetically couple, or couple in any other manner which wouldbe known to one skilled in the relevant art. The adapter 310 may includea hole or gap to vent gases emanating from the spike region to thevariable volume of the variable volume housing portion 312 (e.g., seethe pass-through 336 shown in FIG. 10).

The variable volume housing portion 312 of the receiving assembly 304may fit around the portion of the vial 306 or medication reservoir nothoused by the interface portion 308 or adapter 310. Thus the vial 306may be completely enclosed and sealed from the surrounding environment.In the example embodiment, the variable volume housing portion 312houses the vial body. A variable volume housing 312 may be made of anelastomeric or stretchable material or may include at least one flexibleor expandable segment or feature (e.g. pleats of a bellows).Additionally, it may be desirable that the variable volume housingportion 312 be made of a durable and substantially impermeable material.

The variable volume housing 312 may function as a protective sleeve orjacket for the medication vial receiving assembly 304 and in concertwith the septa 316, 318 prevent any leakage of potentially hazardousfluid into the environment. If pressure or vapors escape from the vial306, the escaping fluid may be captured and retained within the variablevolume housing 312. This may increase the volume of the variable volumehousing 312. The material of the variable volume housing 312 may allowthe variable volume housing 312 to expand or inflate to accommodate theescaping fluid if necessary. In this manner, a variable volume housing312 may allow for any fluid escaping from a medication vial 306 to becontained and sealed within the vial receiving assembly 304.

The interior volume of the variable volume housing 312 may be at ambientpressure when a drug reservoir containment assembly 300 is docked on acompounder dock 302. Alternatively, a drug reservoir containmentassembly 700 may include a port which allows the interior volume of thevariable volume housing to be lowered below ambient pressure or emptiedof fluid after a vial 306 is installed. This may minimize any stretchingof the variable volume housing 312 material in the event that any fluidescapes the vial 306.

The compounder dock 302 may include cooperating receiving structureswhich mate with a mating feature included on the interface portion 308of a drug reservoir containment assembly 300. Any suitable matingarrangement may be used. Additionally, the compounder dock 302 shownincludes a septum 320. In other embodiments, multiple septa or no septummay be included on the compounder dock 302. The septum 320 may be areplaceable component in some embodiments. Similar to the septa 316, 318described in relation to the drug reservoir containment assembly 300,the septum 320 (or septa) of a compounder dock 302 may be made of anelastomeric or self healing material. A spike 322 may also be includedin a compounder dock 302. The spike may pierce through the septum orsepta of the dock 302 and containment assembly 300 into the drugreservoir such that fluid may be drawn out of or introduced into thereservoir. Though only one spike 322 is shown in the example embodiment,other embodiment may include multiple spikes as described above.

FIG. 8 depicts the representational example embodiment of a drugreservoir containment assembly 300 and a compounder dock 302 of FIG. 7with the containment assembly 300 docked to the compounder dock 302.Substances are contained and prevented from entering the ambientenvironment. As shown, the containment assembly 304 has been lowereddown onto the spike 322 of the dock 302 such that the spike 322 haspierced through the septa 316, 318, and 320 and into the vial 306.

In addition to providing a seal against any potentially hazardoussubstances, the septa 316, 318 of the containment assembly 300 mayprovide additional benefits. For example, as the containment assembly300 is removed from the compounder dock 302, the spike 322 will bepulled through the septa 316, 318. Thus the septa 316, 318 serve to wipethe spike 322 when the spike 322 is withdrawn. Any fluid wiped from thespike 322 will be kept on the interior side of the septa 316, 318,facilitating containment. The compounder dock 302 septum 320 may act asa cover for the spike 322 keeping the spike 322 from being exposed. Thismay aid in the prevention of contamination and may facilitate cleaningas only the top face of the septum 320 may need to be cleaned betweenuses.

FIG. 9 depicts a specific example embodiment of a vial receivingassembly 304. As shown, only the interface portion 308, septum 316, andthe variable volume housing portion 312 are visible in FIG. 9. In theexample embodiment, the variable volume housing portion 312 includes abellows 330 which may be in a collapsed state when a vial is installedin the assembly 304. The bellows 330 may expand to accommodate fluid inthe event that there is any fluid (e.g., a gas) escaping an installedvial. In other embodiments, the variable volume housing portion 312 maynot include a bellows 330. Some embodiments may instead use a flaccidbag-like reservoir instead, for example. In such embodiments, theflaccid reservoir may become more turgid in the event any fluid (e.g.,gas) escapes a vial. Also shown in FIG. 9 is a bayonet mount 319 whichis included as part of the interface portion 308 of the containmentassembly 304.

FIG. 10 depicts a cross sectional view taken at the mid plane of thevial receiving assembly 304 shown in FIG. 9. As shown, a vial 306 isinstalled in the vial receiving assembly 304. An adapter 310 is in placearound the neck of the vial 306. The outer edge of the adapter may bethreaded and the interface portion 308 of the vial receiving assembly304 may thread onto the adapter 310. Once fully threaded onto theadapter 310 a gasket 332 may become compressed between a face of theinterface portion 308 and an opposing face of the adapter 310 to createan airtight seal in some embodiments. Other options exist for mating,including but not limited to, a snap fit, sandwich between 308 and 312,etc. In some specific embodiments, there is no gasket 332 or there isthe gasket with a pass-through 336).

Similarly, the variable volume housing portion 312 may thread onto asection of the interface portion 308. This threaded engagement may alsocause a gasket 334 to become compressed between a face of the variablevolume housing 312 and the interface portion 308 creating an airtightseal. The first septum 316 and second septum 318 serve to complete theseal between the interior volume of the vial receiving assembly 304 andthe ambient environment.

As shown the adapter 310 may include a pass-through 336 which places theinterior volumes of the variable volume housing 312 and interfaceportion 308 into fluid communication. If any fluid escapes the vial 306,the fluid may pass through the pass-through 336 and into the variablevolume housing 312.

Using an embodiment in which fluid may pass through the adapter 310allow for simplified manufacture of the adapter 310. The adapter 310may, for example, be made of two pieces of injection mold material whichmay be snapped, press fit, or otherwise joined together around the neckof the vial 306. In some embodiments the adapter 310 may be airtight ornon-airtight.

Though the example embodiment shows the adapter 310 mating with theinterface portion 308 and the variable volume housing 312 mating withthe interface portion 308, this is not limiting and illustrative. Itwould be appreciated by one skilled in the art that these sections maymate in any combination so long as the appropriate seals are created andthe interior volume of the containment assembly 300 is isolated from theambient environment. For example, both the interface portion 308 and thevariable volume housing 312 may mate with the adapter 310. In someembodiments, the adapter 310 may be an integral part of either theinterface portion 308 of the variable volume housing 312. It should alsobe appreciated that other types of interfaces besides threadedinterfaces may be used.

FIG. 11 and FIG. 12 depict alternate embodiments of a drug reservoircontainment assembly 300. The containment assembly 300 shown in FIG. 11is similar to that shown in FIGS. 9 and 10. The variable volume housing312 includes a bellows 330 which allows the volume of the variablevolume housing 312 to increase in the event that fluid escapes thecontained drug reservoir. The variable volume housing 312 in FIG. 11also includes a window portion 350 in the example embodiment. Thiswindow 350 may be transparent and allow a user to view a contained drugreservoir. In the example embodiment, the window 350 is disposed in aposition which would allow a user to read the label on a medication vialand view the contents of the vial.

Referring now to FIG. 12, the variable volume housing 312 of thecontainment assembly 300 is a flaccid elastomeric jacket of bag 352. Theelastomeric jacket or bag 352 may be made of a transparent material andobviate the need for a window 350 similar to that shown in FIG. 11. Inthe event that fluid escapes from a contained medication reservoir, theturgidity of the elastomeric jacket or bag 352 may increase as the fluidis accommodated.

FIGS. 13-15 depict various views of a specific example embodiment of anadapter 310 which may be placed around the neck of a medication vial asa collar. As shown, the adapter 310 may include a first portion 360 anda second portion 362 which may be joined together to surround the neckof a vial. When joined together, an inner void 364 which accommodatesthe neck of a vial may be formed as shown best in FIG. 15. There may bea number of different adapters 310 each having an inner void 364 ofdifferent dimensions in order to accommodate different vials. In suchembodiments, it may be desirable that the adapters 310 for differentvials may be identical with the exception of the dimensions of the innervoid 364. This allows for other components of a containment assembly 300to be standardized.

In the example embodiment, the first portion 360 and the second portion362 are identical pieces. It may be desirable that the first portion 360and second portion 362 of an adapter 310 be identical pieces as it maysimplify manufacturing and installation of the adapter 310. Each portionmay include a pass through 336 as shown in FIGS. 14 and 15. Each portionmay include a mating projection 366 and a receiving structure 368 for amating projection 366. In the example embodiment, the mating projection366 and the receiving structure 368 snap fit together. As mentionedabove, any coupling scheme which would be known to one skilled in theart may alternatively be used.

FIG. 16 depicts another specific example embodiment of an adapter 310.As shown, the adapter 310 is a single monolithic piece of material inthe example embodiment. The adapter 310 includes a hinge 370 which allowportions of the adapter 310 that flank the hinge 370 to swing closedaround the neck of a vial. This hinge 370 may, for example, be a livinghinge and be molded as part of the adapter 310 during manufacture. Theexample adapter 310 includes a projection 372 having a bump feature thatmay fall into a detent 374 when the adapter 310 is closed around theneck of a vial. When then bump feature of the projection 372 falls intothe detent 374, the adapter 310 will effectively lock in place aroundthe neck of a vial.

FIG. 17 depicts a flowchart detailing a number of example steps whichmay be used in creating a desired pharmaceutical compound with acompounder. At block 702, a doctor places an order. The doctor may placethe order with a computerized physician order entry (CPOE) system. Atblock 704, a pharmacist may check the order and confirm that the orderis correct or that there is an issue with the order. The pharmacy systemmay also interface with a CPOE system. If the pharmacy order checkpasses, the order may be sent to the compounder at block 706. At block706, the order may be sent from a CPOE system to the compounder. If thepharmacy order check fails, the issue may be resolved per institutionpolicy at block 722. The compounder may check the order forincompatibilities at block 708. The compounder may have a drug libraryfile stored in its memory and the compounder may refer to the druglibrary file to check for drug names, characteristics,contraindications, other incompatibilities, etc. If the compounder ordercheck fails, the user may be notified at block 712. If the user isnotified of a failed compounder order check at block 712, the issue maybe resolved per institution policy at block 722. If the compounder ordercheck passes, the compounder may compound the order at block 710. Afterthe compounder compounds the order, the compounder may indicate that theorder has been completed at block 714. At block 714, the compounder mayindicate to other hospital or institutional systems (e.g. CPOE system)that the order has been completed. At block 716, the compounder mayprint a label for the compounded medication. In some embodiments, thecompounder may distribute the compounded order into multiple reservoirs.In such embodiments, the compounder may print multiple labels for thecompounded medication. If a label is printed, the compounded medicationmay be labeled at block 718. At block 720, the log data for thecompounder may be saved and/or communicated to other pharmacy orinstitution systems such as a continuous quality improvement (CQI)system, which may be used for analysis of compounder usage and qualityimprovement. In some embodiments, a CQI system may interface with thecompounder to generate materials for regularly scheduled reviews. Thecompounded medication may be transported to the patient floor foradministration at block 724. In some embodiments, some orders may bestockpiled if the orders lend themselves to such stockpiling (e.g. theorders would not expire in a short time period).

FIG. 18 depicts a flowchart detailing a number of example steps whichmay be used by a compounder when placing a reservoir on a manifold. Atblock 802, the compounder may receive a command to dock a reservoir on amanifold. At block 804, the compounder may identify a list of openmanifold ports. At block 806, the compounder may check the list of openmanifold ports and may create a second list of available manifold portson manifolds which do not have a related contraindicated drug docked.The compounder may have a drug library file stored in its memory and thecompounder may refer to the drug library file to check forcontraindications at block 806. At block 808, the compounder may checkthe second list and may create a third list of ports on manifolds thatare made from compatible materials. The compounder may refer to the druglibrary file to check for compatible materials at block 808. At block810, the compounder may select a port which will best optimizethroughput. For example, the compounder may select a more efficientlylocated port, such as a port located in close proximity to the currentposition of a gantry or the like. As another example, the compounder mayplace commonly combined medications on separate manifolds permittingsimultaneous delivery from both manifolds when the medications are beingcombined. This may be useful to increase throughput of the device. Atblock 812, the compounder may dock the reservoir to the selected portwith the gantry or the like.

FIG. 19 depicts a flowchart detailing a number of example steps whichmay be used by a compounder to manage a medication order queue when anew order is received. At block 902, the compounder receives a neworder. The order may be received by the compounder from a CPOE system.At block 904, the compounder may check to see when the compounded orderis required. At block 906, the compounder may queue the order such thatit is scheduled to be completed by required time. At block 908, thecompounder may check the shelf life of the order once the order iscompounded. If the compounded order does not have a long shelf life, thecompounder may keep the queue order at block 910. If the compoundedorder does have a long shelf life but is needed before the soonest offpeak time, the compounder may keep the queue order at block 910. An offpeak time may be, for example at night (e.g. 1:00 a.m.), whencompounding demand is lower. If the compounded order has a long shelflife and is not needed before soonest off peak time, the compounder maychange the queue order at block 912 such that the order is scheduled tobe compounded at an off peak time.

In various embodiments, a compounder may take other information intoconsideration when determining a queue location for a new order. In someembodiments, when the compounder is determine where to place a new orderin an existing queue, the compounder may search the queue for identicalorders or orders for which the same drug cocktail is being compounded.The compounder may then combine these orders and instruct the user toset up multiple destination reservoirs (one or more for each order ofthe combined orders) when the queue location is reached. In someembodiments, the compounder may queue the order in a manner which wouldhelp maximize efficiency of the compounder. For example, the compoundermay queue orders such that orders using similar drugs are groupedtogether to allow the compounder to have a higher throughput. This maybe so because it will minimize the number of times manifolds may need tobe flushed. By means of example, if five orders all use a particulardrug and no other drug on that manifold is needed to produce the order,that compounder may not need to flushed during compounding of those fiveorders.

FIG. 20 depicts a flowchart detailing a number of example steps whichmay be used by a compounder which is included in an integrated system toschedule compounding of drugs. The flowchart depicted in FIG. 204assumes that the steps described above in FIG. 17 have been completedand there is compounded medicine available to start the therapy. Atblock 1002, a therapy is programmed. At block 1004, the therapy isstarted. If the therapy was not altered (e.g. titrated), the therapycompletes at block 1006. If the therapy will require additionalmedication to be compounded, the compounder may receive therapyinformation at block 1008. At block 1010, the compounder queues thecompounding of the additional medication such that the additionalmedication is scheduled to be compounded by the time needed based ontherapy parameters programmed for the therapy or medication regimen ofthe patient receiving the therapy. If the therapy is altered (e.g.titrated) after the therapy is started at block 1004 and if additionalcompounding was required, the compounder may receive altered therapyinformation at block 1012. At block 1014, the compounder changes thequeue order so that medication will be compounded by the time it isneeded. After the compounder queues the order in block 1010 or block1014, the compounder may begin compounding the order at block 1016 whenthe queue location is reached. At block 1018, the order compounding isfinished. At block 1020, the order is labeled and transported to thepatient floor. At block 1022, the medication reservoir associated withthe delivery device is drained and replaced with the compounded order.During one therapy, the above described cycle may be repeated once orseveral times if the therapy requires additional medication to becompounded. If further compounding is required, the compounder mayreceive therapy information at block 1008 and repeat the discussed cyclethrough block 1022. When no further compounding is required, the therapycompletes at block 1006. Alternatively, the example steps above may beutilized to meet the needs of a medication regimen rather than anindividual therapy. The medication regimen may be defined in anotherhospital or institution system which interfaces with the compounder(e.g. an auto-programming system, patient medical record system,auto-refill order system, CPOE system, etc.).

FIG. 21 depicts a flowchart detailing a number of example steps whichmay be used in creating, with a compounder, a desired pharmaceuticalcompound having a manual additive. At block 1102, an order is sent to acompounder. At block 1104, the compounder receives the order. The ordermay be received by the compounder from a CPOE system. At block 1106, thecompounder compounds the order. At block 1108, the compounder mayindicate that is has completed compounding the order. The compounder maycommunicate to other hospital or institution system, such as a CPOEsystem, that the compounder has completed compounding the order. Atblock 1110, the compounder may indicate that manual additive should beadded to the destination reservoir. In some embodiments, a user mayspecify the name of the additive or one or more characteristics of theadditive (e.g. specific gravity). At block 1112, the compounder checksthe destination reservoir for a change in weight indicating thatadditive has been manually added. The compounder may check thedestination reservoir for a change in weight by utilizing a load cellsuch as load cell 126 shown in FIG. 6. At block 1114, the compounder mayprovide labels as needed for the compounded drug with manual additive.At block 1116, the user may affix the label(s) to the destinationreservoir(s). At block 1118, the log data for the compounded order maybe saved. At block 1120, the order may be transported to the patientfloor for administration.

Various alternatives and modifications can be devised by those skilledin the art without departing from the disclosure. Accordingly, thepresent disclosure is intended to embrace all such alternatives,modifications and variances. Additionally, while several embodiments ofthe present disclosure have been shown in the drawings and/or discussedherein, it is not intended that the disclosure be limited thereto, as itis intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Therefore, the abovedescription should not be construed as limiting, but merely asexemplifications of particular embodiments. And, those skilled in theart will envision other modifications within the scope and spirit of theclaims appended hereto. Other elements, steps, methods and techniquesthat are insubstantially different from those described above and/or inthe appended claims are also intended to be within the scope of thedisclosure.

The embodiments shown in drawings are presented only to demonstratecertain examples of the disclosure. And, the drawings described are onlyillustrative and are non-limiting. In the drawings, for illustrativepurposes, the size of some of the elements may be exaggerated and notdrawn to a particular scale. Additionally, elements shown within thedrawings that have the same numbers may be identical elements or may besimilar elements, depending on the context.

Where the term “comprising” is used in the present description andclaims, it does not exclude other elements or steps. Where an indefiniteor definite article is used when referring to a singular noun, e.g. “a”“an” or “the”, this includes a plural of that noun unless somethingotherwise is specifically stated. Hence, the term “comprising” shouldnot be interpreted as being restricted to the items listed thereafter;it does not exclude other elements or steps, and so the scope of theexpression “a device comprising items A and B” should not be limited todevices consisting only of components A and B. This expression signifiesthat, with respect to the present disclosure, the only relevantcomponents of the device are A and B.

Furthermore, the terms “first”, “second”, “third” and the like, whetherused in the description or in the claims, are provided fordistinguishing between similar elements and not necessarily fordescribing a sequential or chronological order. It is to be understoodthat the terms so used are interchangeable under appropriatecircumstances (unless clearly disclosed otherwise) and that theembodiments of the disclosure described herein are capable of operationin other sequences and/or arrangements than are described or illustratedherein.

What is claimed is:
 1. A containment assembly for enclosing a medicationcontainer, the containment assembly comprising: an interface portionhaving a proximal end and a distal end, the interface portion includinga housing wall which defines a channel spanning from the proximal end tothe distal end; at least one pierceable septum disposed at least at oneof: on the proximal end of the channel, and within the channel forming abarrier between the proximal end of the channel and the distal end ofthe channel; a variable-volume housing portion having a variable volumechamber, the variable-volume chamber of the variable-volume housingportion being in fluid communication with the distal end of the channel,wherein the distal end of the interface portion includes a matingfeature which mates with a cooperating mating feature of thevariable-volume housing portion; and a gasket member configured tocompress between the interface portion and the variable-volume housingportion when the interface portion is mated to the variable-volumehousing portion.
 2. A containment assembly for enclosing a medicationcontainer, the containment assembly comprising: an interface portionhaving a proximal end and a distal end, the interface portion includinga housing wall which defines a channel spanning from the proximal end tothe distal end; at least one pierceable septum disposed at least at oneof: on the proximal end of the channel, and within the channel forming abarrier between the proximal end of the channel and the distal end ofthe channel; and a variable-volume housing portion having a variablevolume chamber, the variable-volume chamber of the variable-volumehousing portion being in fluid communication with the distal end of thechannel; and an adapter member having a mating feature configured tomate with a cooperating mating feature on one of the interface portionand the variable-volume housing portion.
 3. The containment assembly ofclaim 2, wherein the adapter member is a collar which is adapted to fitaround a portion of the medication container.
 4. The containmentassembly of claim 2, wherein the adapter member is a collar which isadapted to fit around a neck of the medication container.
 5. Thecontainment assembly of claim 2, wherein the adapter member includes atleast one pass-through allowing for fluid communication between thedistal end of the channel and the variable-volume chamber.
 6. Acontainment assembly for enclosing a medication container, thecontainment assembly comprising: an interface portion having a proximalend and a distal end, the interface portion including a housing wallwhich defines a channel spanning from the proximal end to the distalend; at least one pierceable septum disposed at least at one of: on theproximal end of the channel, and within the channel forming a barrierbetween the proximal end of the channel and the distal end of thechannel; and a variable-volume housing portion having a variable volumechamber, the variable-volume chamber of the variable-volume housingportion being in fluid communication with the distal end of the channel;and at least two pierceable septa of the at least one pierceable septumdisposed within the channel, a first septum of the at least twopierceable septa disposed proximal the proximal end, a second septum ofthe at least two pierceable septa disposed distal to the proximal endrelative to the first septum.
 7. The containment assembly as in any oneof claims 2 and 6, wherein the distal end of the interface portionincludes a mating feature which mates with a cooperating mating featureof the variable-volume housing portion.
 8. The containment assembly ofclaim 7, further comprising a gasket member configured to compressbetween the interface portion and the variable-volume housing portionwhen the interface portion is mated to the variable-volume housingportion.
 9. The containment assembly as in any one of claims 1, 2, and6, wherein the variable-volume chamber is formed from an elastomericmaterial.
 10. The containment assembly as in any one of claims 1, 2, and6, wherein the variable-volume chamber includes at least one expandablefeature.
 11. The containment assembly of claim 10, wherein the at leastone expandable feature is a collapsible pleat.
 12. The containmentassembly as in any one of claims 1, 2, and 6, wherein thevariable-volume housing portion includes a window.
 13. A containmentassembly for enclosing a medication container, the containment assemblycomprising: an interface portion having a proximal end and a distal end,the interface portion including a housing wall which defines a channelspanning from the proximal end to the distal end; a plurality ofelastomeric septa disposed within the channel forming a barrier betweenthe proximal end of the channel and the distal end of the channel; and avariable-volume housing portion, at least a portion of thevariable-volume housing portion being a variable volume formed of anelastomeric material.
 14. The containment assembly of claim 13, whereinthe variable-volume of the variable-volume housing portion is in fluidcommunication with the distal end of the channel.
 15. The containmentassembly of claim 13, wherein the variable-volume housing portionincludes a pressure port configured for connection to a pressure source.16. The containment assembly of claim 15, wherein the pressure port is avacuum port and the pressure source is a vacuum source.
 17. Thecontainment assembly of claim 13, wherein the variable volume is aflaccid enclosure.
 18. The containment assembly of claim 13, furthercomprising a collar member which couples with one of the interfaceportion or the variable-volume housing portion, the collar member sizedto fit around a neck of the medication container.
 19. The containmentassembly of claim 18, wherein the collar member includes a passage whichallows for fluid communication between the distal end of the channel andthe variable volume.
 20. The containment assembly of claim 18, whereinthe collar member comprises a first part and a second part, the firstand second parts having cooperating coupling features which engage tocouple the first part and the second part together.